Angiolaz VES-1CAM
FDA 510(k) K981819 · Angiolaz, Inc.
510(k) numberK981819
Submission
- Device name
- Angiolaz VES-1CAM
- Applicant
- Angiolaz, Inc.
Bellows Falls, VT, US - Received
- May 22, 1998
- Decision date
- August 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FWF – Camera, Television, Endoscopic, Without Audio
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Specialty
- General, Plastic Surgery
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| K990154 | Karl Storz Direct Coupled Interface (Dci 5) Camera SystemFWF · Traditional | Karl Storz Imaging, Inc. | 06/01/1999SE |
| K982754 | EC-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7P (Pal) & Ec 1000-7N (NTSC)FWF · Traditional | A.Stein - Regulatory Affairs Consulting | 01/08/1999SE |
| K982965 | Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesFWF · Traditional | Richard Wolf Medical Instruments Corp. | 11/23/1998SE |
| K982397 | Ves 3001-M Complete Video Endoscopic SystemFWF · Traditional | Angiolaz, Inc. | 09/10/1998SE |
| K982409 | Ves 1501-MFWF · Traditional | Angiolaz, Inc. | 08/21/1998SE |
| K944707 | Isolated Camera HeadFWF · Traditional | Envision Medical Corp. | 10/07/1994SE |
| K930297 | Fujinon Video Laparoscope, ModifiedFWF · Traditional | Fujinon, Inc. | 03/29/1994SE |
| K934682 | Surgical Video Camera and AccessoriesFWF · Traditional | Medical Dynamics, Inc. | 02/15/1994SE |
| K932628 | Endoscopic Video CameraFWF · Traditional | Stephen Chakoff, Inc. | 10/15/1993SE |
More from Stephen Chakoff, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K994362 | Headlamp HL2000.FSR · Traditional | 05/11/2000SE |
| K992447 | 50 W Metal Halide Illuminator, Ves 0501.FCW · Traditional | 10/20/1999SE |
| K982397 | Ves 3001-M Complete Video Endoscopic SystemFWF · Traditional | 09/10/1998SE |
| K982409 | Ves 1501-MFWF · Traditional | 08/21/1998SE |
| K981821 | Ves 3001/2 Dual Output Video IlluminatorFSS · Traditional | 07/29/1998SE |
| K981827 | Ves 0281-M Complete Video Endoscopic Video SystemFET · Traditional | 07/28/1998SE |
| K933868 | Angiolaz Video Endoscopic System Model CAMLUM1 and AccessoriesGCT · Traditional | 11/10/1993SE |
| K913129 | Angiolaz Angioscope CatheterLYK · Traditional | 12/27/1991SE |
| K902329 | Ultra-Vu AngioscopeLYK · Traditional | 08/22/1990SE |
Questions and answers
When was Angiolaz VES-1CAM cleared by the FDA?
Angiolaz VES-1CAM (K981819) received a 510(k) decision of Substantially Equivalent on August 4, 1998, 74 days after the submission was received.
What is the product code of K981819?
The FDA product code is FWF – Camera, Television, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.